Topic:

Regulatory

Latest Headlines

Latest Headlines

Stomach-draining obesity startup gets $12M in debt to support PMA in mid-2015

Aspire Bariatrics has nabbed a $12 million loan facility from Hercules Technology Growth Capital to wrap up its ongoing U.S. pivotal trial and submit a PMA in mid-2015. The company hopes to launch its stomach content-aspirating product in the U.S. in early 2016.

India warns drugmakers failure not an option for price data due next week

India's National Pharmaceutical Pricing Authority has told drugmakers that failure to hand in drug price and sales data by next week is not an option.

China medical device market to top Japan to claim No. 2 spot globally

China's market for medical devices is expected to pass Japan's this year to become the world's second-largest, topped only by the United States. A consulting firm forecast China's market would pass the $55 billion mark this year.

Intercept Pharma soars after nabbing 'breakthrough' title for blockbuster NASH contender

Intercept Pharmaceuticals has nabbed the FDA's breakthrough therapy designation for obeticholic acid, a closely watched therapy in the pipeline for a blockbuster NASH indication.

Zeltiq gains as FDA clears fat-freezing applicator for lower temps, faster treatment

Zeltiq Aesthetics gained 4% after it said FDA cleared a new applicator that uses lower temperatures to cut the one-hour treatment time almost in half. Zeltiq's CoolSculpting procedure is cleared by FDA for noninvasive fat reduction in the abdomen, flank and thighs.

Branded drug prices leapt almost 15% last year, led by pain pills, COPD and heart meds

It's no secret that branded drugmakers often rely on price hikes to keep U.S. sales growth coming, especially on older meds whose patents are close to the ends of their lives. But according to new data, prices spiked more than 10% last year--a trend that may fuel the payer backlash that's been steadily mounting.

How should IBM's Jeopardy-winning Watson be regulated?

IBM's artificial intelligence tool Watson is an expert at Jeopardy, but it can't answer the question as to whether the technology should be regulated as a medical device. That decision rests with Congress and the FDA, or perhaps lobbyists.

European regulators chart record year for new animal health products

The European Medicines Agency recommended 20 new veterinary drugs for approval in 2014--the highest number of positive opinions it has issued in the past 5 years in animal health.

FDA ups regulation of defibrillators to include PMA submission, citing patient safety concerns

The FDA issued an administrative order requiring PMA approval for new and existing automated external defibrillators, citing manufacturing issues and pointing to the recall of 2 million of the devices since 2005 as justification for the more stringent regulation.

India tweaks presubmission rules on drugs, trials, devices and other regulated products

India's Central Drugs Standard Control Organization wants to tweak the rules on its presubmission process with agency staff and experts.